WITCH HAZEL - HAMAMELIS VIRGINIANA Oral
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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.
Notes
- Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
- The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.
Date
January 28, 2022
Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | Source information | ||
---|---|---|---|---|
Source material(s) | Part(s) | Preparation(s) | ||
Hamamelis virginiana |
|
Hamamelis virginiana |
|
Dry |
References: Proper name: USDA 2019; Common names: Bradley 2006, ESCOP 2003, McGuffin et al. 2000; Source information: Bradley 2006, ESCOP 2003.
Route of Administration
Oral
Dosage Form(s)
This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.
Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.
Use(s) or Purpose(s)
Back or Leaf
(Traditionally) used in Herbal Medicine (as an astringent) to help relieve diarrhoea (Bradley 2006; Blumenthal et al. 2000; Ellingwood 1983; Grieve 1971).
Leaf only
(Traditionally) used in Herbal Medicine (as an astringent) to help relieve symptoms associated with varicose veins (such as painful and heavy legs) (ESCOP 2003; Hoffmann 2003; Felter 1983).
Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Methods of preparation: Dry, Powdered, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
Bark
0.6 - 9 grams of dried bark, per day (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Mills and Bone 2000)
Leaf
1.2 - 12 grams of dried leaf, per day (Bradley 2006; ESCOP 2003; Blumenthal et al. 2000; Mills and Bone 2000)
Direction(s) for use
Take a few hours before or after taking minerals and/or B-vitamin supplements (Brinker 2008; Mills and Bone 2000).
Duration(s) of Use
No statement required.
Risk Information
Caution(s) and warning(s)
- Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding (Barnes et al. 2007; ESCOP 2003).
Contraindication(s)
No statement required
Known adverse reaction(s)
Some people may experience gastric irritation (ESCOP 2003; Berardi et al. 2002; Mills and Bone 2000; McGuffin et al. 1997).
Non-medicinal ingredients
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
Storage conditions
Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).
Specifications
- The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
- The medicinal ingredient mustay comply with the requirements outlined in the NHPID
References cited
- Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): The Pharmaceutical Press.
- Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. 2002. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association.
- Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
- Bradley PR, editor. 2006. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association.
- Brinker F. 2010. Updates and Additions for Herbal Contraindications and Drug Interactions plus Herbal Adjuncts with Medicines, 4th edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2019 July 11]. Available from: https://www.eclecticherb.com/herb-contraindications-drug-interactions
- Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
- ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. 2003. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
- Felter HW. 1983. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications [Reprint of 1922 original].
- Grieve M. 1971. A Modern Herbal, Volume 2. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
- Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
- McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.
- Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
- USDA 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Hamamelis virginiana L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 July 11]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
References reviewed
- BHP 1996: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1996.
- Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated.
- BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 1. London (UK): The Stationary Office.
- BPC 1934: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press.
- BPC 1973: The British Pharmaceutical Codex. London (GB): The Pharmaceutical Press.
- Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
- EMA 2008. European Medicines Agency. Committee on Herbal Medicinal Products. Draft. Community Herbal Monograph on Hamamelis virginiana L., FOLIUM et CORTEX DESTILLATUM and Hamamelis virginiana L., RAMUNCULUS DESTILLATIUM. [Accessed 2019 July 11]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-hamamelis-virginiana-l-folium-et-cortex-destillatum-hamamelis_en.pdf
- Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
- McIntyre A. 2005. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited.
- Meyer JE. 1993. The Herbalist. Glenwood (IL): Meyerbooks.
- Mills S. 1993. The Essential Book of Herbal Medicine. Toronto (ON): Arkana.
- Mills S. 1985. The Dictionary of Modern Herbalism. Wellingborough (GB): Thorsons Publishers Ltd.
- Moerman DE. 1998. Native American Ethnobotany. Portland (OR): Timber Press.
- Ph. Eur. 2008: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
- Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): Medpharm Scientific Publishers.
- Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press.
- USP 32: United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.
- Williamson EM. 2003. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (GB): The C.W. Daniel Company Limited.
- Williamson EM, Evans FJ, Wren RC. 1988. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited.
- Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.
- Zeylstra H. 1998. Hamamelis virginia. British Journal of Phytotherapy 5(1):23-28.